Recently, the National Medical Products Administration gave the green light to import Apple's 'Mobile Pulse Rate Atrial Fibrillation Sign Recording Software' as a Class II medical device. The software, registered under the name Atrial Fibrillation History Feature, received approval on December 26, 2025.
This particular software is tailored for patients aged 22 and older who have already been diagnosed with atrial fibrillation. Its primary function is to retrospectively assess the proportion of time a patient spends experiencing atrial fibrillation episodes. However, it's important to note that it doesn't send out individual alerts when signs of atrial fibrillation are detected. Moreover, it's not meant to replace traditional diagnostic and treatment approaches.
The software comprises two components: one for the watch and another for the phone. To use it effectively, it needs to be paired with the 'Health' App on the iPhone. In response to the approval, Apple stated that it is currently finalizing the necessary procedures. The company is eager to roll out its services to users in mainland China at the earliest opportunity.
